← FDA DRUG APPROVALS

FDA NDA · NDA203094

TYBOST

cobicistat

Sponsor: GILEAD SCIENCES INC

APPLICATION
NDA203094
TYPE
NDA
ORIGINAL APPROVAL
2014-09-24
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TYBOST · ReferenceDiscontinued
COBICISTAT 150MG · TABLET · ORAL
TYBOST · ReferenceDiscontinued
COBICISTAT 90MG · TABLET · ORAL

Approval history

2025-06-20Efficacy · Supplement 17 · standard — Label ↗AP
2025-06-20Efficacy · Supplement 18 · standard — Label ↗AP
2021-09-09Labeling · Supplement 16 · standard — Label ↗AP
2020-08-21Labeling · Supplement 15 · standard — Letter ↗AP
2019-10-03Efficacy · Supplement 14 · priority — Label ↗AP
2019-08-22Efficacy · Supplement 13 · priority — Letter ↗AP
2018-10-30Efficacy · Supplement 12 · priority — Label ↗AP
2018-07-27Labeling · Supplement 11 · standard — Letter ↗AP
2017-08-28Labeling · Supplement 8 · standard — Label ↗AP
2017-05-04Labeling · Supplement 7 · standard — Label ↗AP
2016-06-17Labeling · Supplement 5 · standard — Label ↗AP
2016-04-15Manufacturing (CMC) · Supplement 4 · standardAP
2015-11-25Efficacy · Supplement 3 · standard — Label ↗AP
2015-04-17Manufacturing (CMC) · Supplement 2 · standardAP
2015-04-15Manufacturing (CMC) · Supplement 1 · standardAP
2014-09-24Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
2014-09-24Efficacy · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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